Viewing Study NCT07484568


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Study NCT ID: NCT07484568
Status: COMPLETED
Last Update Posted: 2026-03-20
First Post: 2026-03-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Circuit Training With and Without Upper and Lower Limb Resistance Training in Post-CABG Patients
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004418', 'term': 'Dyspnea, Paroxysmal'}], 'ancestors': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065327', 'term': 'Circuit-Based Exercise'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Medical Research Council (mMRC)', 'timeFrame': 'First day', 'description': 'The mMRC Dyspnea Scale is a validated tool to assess the severity of dyspnea among the patients with pulmonary complications. This scale was utilized to quantify the symptoms of paroxysmal nocturnal dyspnea among the participants in the study, offering an insight to the effectiveness of exercise interventions on the respiratory symptoms'}, {'measure': '1-Repetition Maximum (1-RM)', 'timeFrame': 'First day', 'description': '1-RM is a useful tool in the studies in the studies evaluating the effectiveness of strength training such as those addressing upper and lower limb resistance training. This test specifies the maximum weight that a subject can lift in a single repetition, providing a precise, quantitative baseline evaluation of dynamic strength. It can be used as a solid baseline for tracking and comparing strength changes during intervention. Thus, 1-RM is a practical and objective tool in rehabilitation research. It allows the researchers to analyze the effectiveness of certain treatments and monitor functional changes over the course of treatment or regimen.'}, {'measure': 'Modified Borg Scale (BORG CR-10):', 'timeFrame': 'First day', 'description': 'Modified Borg Dyspnea Scale is a highly validated subjective tool, to assess rate of perceived exertion during exercise to monitor exercise intensity and tailor to individual patient in cardiac rehabilitation settings. It is safe and cost-effective. It has a rating of 0-10 with zero representing (no breathlessness) and 10 (maximal exertion). It is a subjective measure of how hard the body is pushing against exertion during exercise. Specially designed for the assessment of cardiac endurance'}, {'measure': '6-Minute Walk Test 6-MWT:', 'timeFrame': 'First day', 'description': 'It is a reliable tool for assessing functional capacity among the patient population that present with underlying cardiovascular and pulmonary conditions. We used this tool in the assessment of functional capacity among the patients that participated in the study. This test specifically measures the distance covered in 6 minutes. In this test the participant walks along a flat straight pathway (usually 30-meter indoor corridors) in six minutes at their own pace. The maximum distance covered in 6 minutes documented the functional capacity among the participants under study.'}, {'measure': 'Incremental Shuttle Walk Test (ISWT)', 'timeFrame': 'First day', 'description': 'Incremental Shuttle Walk Test (ISWT) is a highly reliable and valid tool for the assessment of cardiac endurance as a distinct outcome separately from overall functional capacity. It measures cardiac endurance under progressively increasing workloads within the safe limits. We used this tool to assess the cardiopulmonary endurance and baseline functional status in CABG population and to measure the improvements post-intervention outcomes. The test is safe, cost-effective and convenient to implement in all the clinical settings requiring little equipment and simultaneously assesses physiological responses such as heart-rate HR, oxygen saturation SPO2, and blood pressure in accordance with the subjective effort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-CABG', 'PND', 'Circuit Training', 'Resistance Training', 'Cardiac Rehabilitaion'], 'conditions': ['Dyspnea, Paroxysmal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.scielo.br/j/rbccv/a/QfbGnFyhNvxCwdLNM7m4Ppg/?format=html&lang=en', 'label': 'Effects of resistance exercise applied early after coronary artery bypass grafting: a randomized controlled trial'}, {'url': 'https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0188551&type=printable', 'label': 'Improvement in cardiac dysfunction with a novel circuit training method combining simultaneous aerobic-resistance exercises. A randomized trial'}, {'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC6196911/', 'label': 'Causes of dyspnea after cardiac surgery'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the contrasting effects of circuit training with and without upper and lower limb resistance training on paroxysmal nocturnal dyspnea, functional capacity and endurance on post-CABG patients.', 'detailedDescription': 'A randomized controlled trial underlined that dynamic strength training dramatically increased peripheral muscular strength and power when combined with endurance training, which may enhance patient prognosis, according to a study done on patients with cardiovascular disease. According to the study, dynamic strength training is therefore advised as a crucial part of cardiovascular rehabilitation. The results showed that strength training was associated with lesser increases in intra-arterial blood pressure and cardiac output, indicating sufficient cardiovascular safety. All things considered, this study questions accepted therapeutic practice and reignites the discussion about the best dynamic strength training. highlighted the importance of lower limb muscle strengthening in an RCT following CABG surgery; Phase II cardiac rehab showed significant gains in lower limb strength and overall physical and cardiorespiratory performance 6 weeks following hospital discharge, as determined by the Short Physical Performance Battery and 6MWT. Although, cardiac rehabilitation following coronary artery bypass graft (CABG), has been shown to increase functional capacity and quality of life. Significant gaps exist in determining the exact exercise prescription for symptom alleviation and functional recovery. Existing researches primarily focused on conventional continuous aerobic training (CAT) or the circuit-based training alone, with little attention on targeted upper and lower limb resistance training in clinical settings. Furthermore, the majority of the literature assesses the outcomes such as peak oxygen uptake (V̇O₂max), six-minute walk distance (6-MWD) or general dyspnea scores. While paroxysmal nocturnal dyspnea is clinically significant and unpleasant condition among post-CABG patients, is understudied. Dyspnea is usually examined using non-specific tools and techniques during rehabilitation programs but a few studies used cardiac-specific symptom classification tools in post-CABG rehabilitation. In addition, there is a lack of randomized clinical trials that investigate combined effects of circuit-resistance training in Phase-II cardiac rehabilitation on multiple domains like dyspnea severity, muscle strength, endurance and functional capacity within a single-structured rehabilitation program. Some studies include small sample sizes or shorter study durations which limit the validity of the findings and the ability to derive clinically significant conclusions. Furthermore, insufficient information is available from low and middle-income nations where patient characteristics and healthcare resources are differ from those in high-income countries. This emphasizes the importance of doing context-specific to help define evidence based cardiac rehabilitation procedures. Therefore, the current study addresses the gaps by systematically comparing the effects of circuit training with and without targeted upper and lower limb resistance training using a complete set of outcome variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Adult CABG surgery candidates aged between 35 and 65 years who underwent uncomplicated CABG surgery within past 3-6 months.\n\n * No history of pre-existing pulmonary disease.\n * Clinically stable cardiac status and approval for participation in phase-II cardiac rehabilitation from the cardiac surgeon.\n * Patients that presented with the symptoms of mild to moderate levels of paroxysmal nocturnal dyspnea (PND). (38)\n * Willingness and availability to participate in the phase-II cardiac rehabilitation program for the study duration.\n * Physical ability to perform both upper and lower limb strength training exercise.\n * Absence of pre-existing severe orthopedic limitations that could interfere with the exercise performance.\n\nExclusion Criteria:\n\n* Uncontrolled hypertension, cardiac arrhythmias or any unstable cardiovascular complication that was an absolute contraindication to participate in clinical exercise program.\n* Severe pre-existing pulmonary conditions such as COPD or Asthma that could interfere with exercise capacity.\n* Severe orthopedic limitations such as arthritis, recent fractures and sternal site infections post-surgery.\n* Neurological complications, including stroke, severe neuropathy, balance and coordination abnormalities that could impede physical performance.\n* Cognitive impairments that may possibly affect the ability to understand and follow the exercise protocols.\n* Participation in some other structured rehabilitation program within the past month.'}, 'identificationModule': {'nctId': 'NCT07484568', 'briefTitle': 'Circuit Training With and Without Upper and Lower Limb Resistance Training in Post-CABG Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Circuit Training With and Without Upper and Lower Limb Resistance Training on Paroxysmal Nocturnal Dyspnea, Functional Capacity and Endurance in Post-CABG Patients', 'orgStudyIdInfo': {'id': 'S24C14G36005 Aaima'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Circuit Training with upper and lower limb Resistance Training', 'description': 'A series of exercises in a circuit format with Resistance Training: for upper and lower limbs (30-40% of 1-RM)', 'interventionNames': ['Other: Circuit Training with upper and lower limb Resistance Training']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Circuit Training only', 'description': 'Exercises in circuit format (30-40 minutes)', 'interventionNames': ['Other: Circuit Training Exercises']}], 'interventions': [{'name': 'Circuit Training with upper and lower limb Resistance Training', 'type': 'OTHER', 'description': 'A series of exercises in a circuit format, with 1 minute of exercise followed by 30 seconds of rest. The circuit was repeated 2-3 times, with a 2-minute break between circuits along with upper and lower limb Resistance exercises (30-40% of 1-RM) using weights and therapeutic bands', 'armGroupLabels': ['Group A: Circuit Training with upper and lower limb Resistance Training']}, {'name': 'Circuit Training Exercises', 'type': 'OTHER', 'description': 'A series of exercises in a circuit format, with 1 minute of exercise followed by 30 seconds of rest. The circuit was repeated 2-3 times, with a 2-minute break between circuits.', 'armGroupLabels': ['Group B: Circuit Training only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Punjab Institute of Cardiology', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Qurat ul Ain, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}